Balloon catheters and methods for treating paranasal sinuses

ABSTRACT

A set of sinus balloon catheters are provided for treating a patient&#39;s paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities. These include a balloon catheter with a bend placing a distal segment at 90° to a proximal segment and a balloon catheter which is substantially straight. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, or sinus to be excised. The catheters have appropriate inflated working diameters and appropriate outer diameters with the balloon deflated that will enable the catheter to be pushed into the respective prepared opening, natural ostium or duct, or sinus cavity to be excised. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, and/or to dilate sinus cavities to remove them.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/259,300 filed on Sep. 30, 2002, the entire disclosure of which isexpressly incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to balloon catheters and methods using suchcatheters for treating paranasal sinuses.

BACKGROUND OF THE INVENTION

To fully understand the invention, it is necessary to consider theanatomy and physiology of the sinus system. FIGS. 4-16, which showvarious steps of methods of the invention, also show important featuresof sinus anatomy. The maxillary sinus 21 lies lateral to the nasalcavity 38, inferior to the eye orbit 23 and superior to the palate orroof of the mouth. The medial wall of the maxillary sinus forms thelateral nasal wall 44 inferiorly. The frontal sinus 35 (FIG. 16) liesabove the orbit and its floor is formed by the frontal bone and iscontiguous with part of the orbital roof. The right and left frontalsinuses are divided by the interfrontal septum. The frontal sinus drainsinto the nasal cavity and its outflow tract is in the inferomedialsinus, which connects to the frontonasal duct 36. Frontonasal duct 36empties into the nasal cavity through lateral nasal wall 44 under themiddle turbinate 20.

The ethmoid sinus is divided into anterior and posterior ethmoid aircells 29 and 31. The ethmoid sinus consists of multiple spaces or cellsdivided by thin bony septae. The ethmoid sinus is contained in theethmoid bone. The lateral wall of the ethmoid sinus composes the medialwall of the orbit. The medial wall of the ethmoid sinus composes thelateral wall 44 of the nasal cavity superiorly. Anterior ethmoid aircells 29 drain through lateral nasal wall 44 into the middle meatus 22beneath middle turbinate 20.

The sphenoid sinus 39 is posterior to the ethmoid sinus 29 and 31.Sphenoid sinus 39 has a lateral wall that is adjacent to the opticnerve, carotid artery, and cavernous sinus. The floor of sphenoid sinus39 lies above maxillary sinus 21 and pterygopalatine fossa. Lateralnasal wall 44 is partially covered by inferior 46, middle 20, andsuperior 17 turbinates.

Sinus physiology will now be considered. The mucosa of nasal cavity 38contains secretory elements (mucosal glands and goblet cells) and adense ciliary layer. The paranasal sinuses are covered by a similarmucosa, although the secretory cells and cilia may be sparser in themore remote areas of the sinuses. The secretory cells produce a largevolume of mucus that is normally actively transported by the cilia(mucociliary transport) in a specific pattern (not a gravity dependantpattern) from the sinus through the opening between the sinus and thenasal cavity (sinus ostium). Cellular debris and bacteria aretransported in the mucus from the sinus cavity through the ostium intothe nose.

Inflammation of the sinus and nasal mucosa causes hyperemia, lymphaticswelling, stasis in the blood and lymphatic pathways and leads toincreased secretion of mucus and reduced mucociliary transport. Theinflammation may be caused by allergies, noxious agents, nasal polyps,and other factors. Over time there is a pathologic increase ininflammatory cells, ground substance, and fibers with a permanentdisruption of mucociliary transport and lymphatic drainage. Anobstruction of the narrow ducts and ostia between the paranasal sinusesand nasal cavity develops, resulting in a vicious cycle of increasedsecretions, edema, and ultimately organized connective tissue andmucosal hyperplasia. Bacteria are not cleared from the sinuses andmultiply in the fertile inflammatory environment worsening the chronicsinus inflammation (sinusitis).

Treatment with antibiotics, corticosteroids in nasal sprays orsystemically, and antihistamines may result in resolution of sinusitis.However some patients become resistant to medical treatment and surgerybecomes necessary.

Modern sinus surgery is usually performed endoscopically and is based onthe principle of restoring patency of the sinus ducts and ostia byenlarging the opening and allowing mucociliary clearance of mucus fromthe sinus into the nose to resume. If mucociliary clearance isre-established, then the inflammatory changes in the sinus mucosadescribed above will resolve. In classic sinus surgery, an incision wasmade along the side of the nose in the medial canthus to access theethmoid or sphenoid sinuses. This incision could be extended to beneaththe medial half of the brow to also access the frontal sinus. Anincision through the gums above the upper teeth and creation of a largebony opening in the maxilla with excision of large areas of sinus mucosawas used to perform maxillary sinus surgery. A large opening was createdthrough the medial wall of the maxillary sinus into the nose in theinferior meatus (maxillary antrostomy) to allow postoperative drainageof the sinus.

The development of endoscopic sinus surgery allowed sinus surgery to beperformed from an intranasal approach, thus eliminating the need forexternal incisions, the creation of very large bony openings, andreducing morbidity. However, endoscopic sinus surgery requires theexcision of large areas of bone and nasal mucosa and has reportedcomplications of blindness from damage to the optic nerve, double visionfrom damage to the orbit and medial rectus muscle, damage to thenasolacrimal duct resulting in tearing and dacryocstitis, leakage ofcentral nervous system fluid and infection of the brain and meninges,loss of the sense of taste, and pain and neuralgia of the face andscalp, and infection of the skull base.

As shown in U.S. Pat. Nos. 5,021,043 and 5,169,043, I have previouslyco-invented balloon catheters for use in the lacrimal system. In myapplication “Transnasal Method and Catheter for Lacrimal System,” filedherewith, I teach that a balloon catheter can be introduced transnasallyto treat the lacrimal system.

A review of the prior art shows a number of patents (Katz U.S. Pat. No.6,027,478; Brennan U.S. Pat. No. 4,883,465; Akiyama U.S. Pat. No.4,102,342; Payton U.S. Pat. No. 4,338,941; Katz U.S. Pat. No. 5,454,817;Stangerup U.S. Pat. No. 5,546,964 and Shippert U.S. Pat. No. 5,827,224)which teach the use of expandable devices (usually a balloon) into thenasal cavity or sinuses. Most of these are for the treatment of nosebleeds or the control of bleeding.

A number of articles disclose the use of a balloon catheter in sinusesto hold fractured bones in place, stop bleeding by tamponade, preventfluid from flowing out of the nose into the pharynx, or to maintain alow intranasal air pressure. In one case, a catheter was used to stent aduct after surgery; and the balloon was inflated in the sinus to deepthe stent in position. However, there are no teachings in the prior areto use a balloon catheter to create a new opening from a sinus into thenose, to dilate an ostium or duct, or excise a sinus. A balloon wasnever used to directly treat sinus disease.

SUMMARY

The present inventions teaches the use of sinus balloon catheters totreat sinus disease by creating a new opening from a sinus into thenose, to dilate a sinus ostium or duct, or to excise a sinus. Theballoon catheters of the invention constitute a set of catheters havingdifferent configurations and dimensions suitable for the treatment ofdifferent parts of the paranasal sinus system. The catheters comprise ahypotube formed of stainless steel of sufficient stiffness and columnstrength to be pushed through a surgically prepared small, tight openingfrom a sinus into the nose, through a sinus ostium or duct, or into asinus cavity. The small opening may be created surgically or may be thenatural ostium or duct of the sinus.

One of the balloon catheters used in the invention has a proximalsegment and a circular bend placing a distal segment at an angle of 70°to 115°, preferably 90° to the proximal segment. A balloon is mountedover the distal segment which has a slot permitting a fluid under thepressure applied to the proximal end of the proximal segment to inflatethe balloon.

The angled distal segment allows the surgeon to rotate or shift theposition of the long proximal catheter shaft, thus positioning thedistal segment to enter from the nasal cavity into the sinus at variousangles appropriate to each individual patient. The balloon catheter withthe 90 degree angle is used to treat maxillary and frontal sinusdisease.

The distal segment of the balloon catheter from the outside of the bendto the end of the catheter is 14 mm. The length of the distal segment isshort enough to allow it to be rotated within the nasal cavity and thusenter from the nasal cavity into the sinus at the desired angle. Thedistal segment is long enough to allow a balloon of sufficient lengthand diameter to be attached to the hypotube for dilation of an openingthrough the lateral nasal and sinus wall, duct, or ostium. The balloonmaterial is attached with adhesive to the very distal portion of thedistal segment and to the proximal portion of the distal segment, thebend, and the very distal portion of the long proximal segment. A longerworking segment of balloon can be used because the area of adhesion ofthe balloon includes the bend and the distal portion of the proximalsegment. A 9 mm inflated diameter angled balloon is used to treat themaxillary sinus and a 5 mm inflated diameter angled balloon is to treatthe frontal sinus.

Another balloon catheter of the invention is straight or has a minimalangle at the junction of the distal segment and the proximal segment.This balloon catheter is used for ethmoidectomy and sphenoid sinusotomyand uses a balloon with an inflated diameter of 9 mm. Each of theballoon catheters of the invention have a sufficiently small deflatedprofile to fit through the sinus ostium, duct, or opening in the nasalwall or scar tissue into the sinus.

It is useful to apply a lubricious coating to the balloon material tofacilitate pushing it through the lateral nasal wall and sinus wall intothe sinus. The proximal catheter shaft has a luer lock with wings or anexpansion to allow the catheter to be attached to tubing from theinflation device. The wings allow the surgeon to more easily manipulatethe balloon catheter.

The methods of the invention open or enlarge an obstructed or narrowedostium or duct of a sinus using a balloon and allow the sinus to draininto the nose. This is accomplished without causing damage to thesurrounding structures such as the optic nerve, extraocular muscles thatmove the eye, the orbit, brain, meninges, or nasolacrimal duct.

Another method of the invention removes a sinus and cures sinus diseasewithout damage to the surrounding structures such as the optic nerve,extraocular muscles, orbit, brain, meninges, and nasolacrimal duct. Themethods of the invention are useful for opening a sinus ostium or ductwhich has been narrowed or obstructed by scar tissue from previoussurgery or trauma, for creating a new opening in the wall of a sinuswhich has scar tissue to allow proper drainage of the sinus into thenose, and for removing a sinus which has scar tissue.

The methods of the invention include a balloon catheter antrostomy ofthe maxillary ostium, a balloon catheter middle meatal maxillaryantrostomy, a balloon catheter inferior meatal antrostomy, a ballooncatheter ethmoidectomy of the anterior ethmoid sinus, a balloon catheterethmoidectomy of the posterior ethmoid sinus, a balloon cathetersinusotomy of the sphenoid sinus, and a balloon catheter frontalsinusotomy.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of one embodiment of the sinus ballooncatheter of the invention;

FIG. 2 is a closeup schematic drawing of the tip of the distal segmentof the sinus balloon catheter of FIG. 1;

FIG. 3 is a schematic drawing of a second embodiment of a sinus ballooncatheter of the invention;

FIG. 3 a is a closeup schematic drawing of the tip of the sinus ballooncatheter of FIG. 3;

FIG. 4 is a schematic drawing of a step of a method of the invention,showing the uncinate process being removed with a punch to expose theethmoid infundibulum and semilunar hiatus;

FIG. 5 is a schematic drawing of another step of the method of FIG. 4showing the sinus balloon catheter dilating and thereby enlarging theostium of the maxillary sinus;

FIG. 6 is a schematic drawing of a step of a second method of theinvention showing the Blakesely punch creating a small opening in thefontanelle of the lateral nasal wall in the middle meatus thus creatinga communication between the maxillary sinus and nasal cavity;

FIG. 7 is a schematic drawing of another step of the method of FIG. 6showing the sinus balloon catheter dilating the opening in thefontanelle of the lateral nasal wall in the middle meatus thus creatinga large communication opening (antrostomy) for drainage from themaxillary sinus into the nasal cavity;

FIG. 8 is a schematic drawing of a step of a third method of theinvention showing the dissector perforating the lateral nasal wall inthe inferior meatus into the maxillary sinus;

FIG. 9 is a schematic drawing of another step of the method of FIG. 8showing the sinus balloon catheter dilating the opening in the lateralnasal wall in the inferior meatus thus creating a large antrostomy fordrainage from the maxillary sinus into the nasal cavity;

FIG. 10 is a schematic view of a fourth method of the invention showingthe cutting forceps making a new opening in the anterior wall of theethmoid bulla;

FIG. 11 is a schematic view of another step of the method of FIG. 10showing the straight sinus balloon catheter dilating the ethmoid bulla;

FIG. 12 is a schematic view of yet another step of the method of FIG. 10showing the straight sinus balloon catheter dilating the ethmoid aircells and thus completing the anterior ethmoidectomy;

FIG. 13 is a schematic view of yet another step of the method of FIG. 10showing a punch perforating the basal lamella of the middle turbinate;

FIG. 14 is a schematic view of still another step of the method of FIG.10 showing the straight sinus balloon catheter dilating the posteriorethmoid air cells and thus completing the posterior ethmoidectomy;

FIG. 15 is a schematic view of an additional step of the method of FIG.10 showing the sinus balloon catheter dilating the anterior wall of thesphenoid sinus;

FIG. 16 if a schematic view of a further step of the method of FIG. 10showing the angled sinus balloon catheter dilating the frontonasal duct.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in FIGS. 1 and 2, a first embodiment of a sinus ballooncatheter 130 of the invention is assembled from a tube 136, preferably astainless steel hard tempered hypotube which has a circular bend 138 of0.13″ radius such that distal segment 137 is oriented 70° to 115°,preferably 90°, to proximal segment 139. A slot 140 is provided insegment 137. The distance from the distal tip 184 of distal segment 137to the outer wall of proximal segment 139 of hypotube 136 is 4 mm to 30mm, preferably 14 mm, as shown in FIG. 1. The distal tip 184 of thehypotube 136 is closed, whereas the proximal end 142 is open. However,the lumen of tube 136 may be closed in distal segment 137, up to 10 mmfrom distal tip 184, allowing distal tip 184 to remain open. In eithercase, tube 136 is closed distally of slot 140. The proximal end 142 ofhypotube 136 is inserted into a mold for forming luer 144 and plastic isinjected into the mold to form luer 144 attached to the end of proximalsegment 139. The inner diameter of the luer 144 matches the externaldiameter of the hypotube 136. The luer 144 has wings 143 or otherenlargement or expansion on it to enable the surgeon to better hold andmanipulate balloon catheter 130. Catheter 130 is 4″ to 10″ long,preferable 6″ in length as measured from proximal end 142 to distal tip184, as shown in FIG. 1. The wall of tube 136 should be of suchthickness that the tube has sufficient stiffness and column strengthwith marked resistance to lateral bending that distal segment 137 can bepushed through a prepared small, tight opening from a sinus into thenose, pushed through a sinus ostium or duct, or pushed into a sinuscavity which may require considerable pressure in some cases. It hasbeen found that a tube with a wall thickness of at least 0.035 inch willbe satisfactory. A preferred tube has an outer diameter of 0.083″ and aninner diameter of 0.039″ with a wall thickness of 0.044″.

Port 140 in distal segment 137 is formed by inserting temporarily adiscardable wire segment into the tube 136. This is done beforeinserting hypotube 136 into luer 144. A transverse slot is cut in thetube 136 approximately 2 mm to 14 mm, preferably 4 mm, from its distalend 184 to form port 140. The slot extends in depth to approximately onethird of the diameter of tube 136. A wire wheel is used to remove anyburrs, and the discardable core wire is removed and discarded.

A balloon 134 is preferably formed of polyethylene terephthalate and hasa length of approximately 4 mm to 30 mm, preferably 14 mm, and a workinginflated diameter of 2 mm to 14 mm, preferably 9 mm, for use in thesinus system, except for use in the nasofrontal duct where thepreferable inflated working diameter is 5 mm. The balloon has a distalneck 170, a distal tapered region 172, a center region 174, a proximaltapered region 176, and a proximal neck 178. During installation, tube136 is cleaned with isoproponol and then coated with a primer, “Loctite770.” The balloon is placed over the distal end of tube 136 to align thedistal end of distal neck 170 with distal end 184 of tube 136. Anadhesive, such as cyanoacrylate, is used. An acceptable adhesive“Loctite 4081” is available from Loctite Corporation. The adhesive isapplied to distal end of distal neck 170 and the proximal end ofproximal neck 178 to form bonds 180 and 182, respectively. The adhesiveis applied to the balloon necks 170, 178 using a small mandrel such as awire approximately 0.010″ to 0.014″ in diameter. The adhesive wicks intothe necks due to capillary action. Proximal neck 178 may be bonded ondistal segment 137 of tube 136 or extend over bend 138 onto the distalend portion of proximal segment 139 of tube 136. Extension of theproximal neck 178 onto bend 138 and proximal segment 139 allows agreater length of the working diameter, i.e., center region 174, to beon distal segment 137 of tube 136.

A second embodiment of sinus catheter of the invention is shown in FIG.3. The catheter 230 is assembled from a tube 236, formed of stainlesssteel hard tempered hypotube which is straight or has a mild circularbend distally such that distal segment 237 is oriented 130 to 180,preferably 180 degrees, to a long proximal segment 239. The distancefrom the distal tip 284 of distal segment 237 to the outer wall ofproximal segment 239 of hypotube 236 is 10 to 100 mm, preferably 16 mm.The distal tip 284 of the hypotube 236 preferably is closed whereas theproximal end 242 is open. However, the lumen of tube 236 may be closed 0to 10 mm from distal tip 284 allowing distal tip 284 to be open. Theproximal end 242 of hypotube 236 is inserted into a mold for formingluer 244. Heated plastic is injected into the mold to form luer 244attached to the end of proximal segment 239. The inner diameter of luer244 matches the external diameter of hypotube 236. The luer 244 haswings 243 or expansions on it to enable the surgeon to better hold andmanipulate balloon catheter 230.

Catheter 230 has a port 240 in distal segment 237 which is formed byinserting temporarily a discardable wire segment into the tube 236. Thisis done before inserting hypotube 236 into luer 244. A transverse slotis cut in tube 236 approximately 2 to 14 mm, preferably 4 mm, from itsdistal end 284 to form port 240. The slot extends in depth toapproximately ⅓ of the diameter of tube 236. A wire wheel is used toremove any burrs, and the discardable core wire is removed anddiscarded.

It is desirable for the catheter 230 to have column strength and markedresistance to lateral bending. The deflated catheter must be capable ofbeing pushed through an initial prepared small opening in the nasal orsinus wall, an ostium or duct, and into a sinus cavity. This may requireconsiderable pressure in some cases.

A balloon 234, preferably formed of polyethylene terephthalate, has alength of approximately 4 to 30 mm, preferably 14 mm, and an inflatedworking diameter of 3 to 15 mm, preferably 9 mm. The balloon has adistal neck 270, a distal tapered region 272, a center region 274, aproximal tapered region 276, and a proximal neck 278. Necks 270 and 278are bonded to hypotube 236, forming bonds 280 and 282, in the samemanner as is described above with respect to the attachment of necks 178and 170 to hypotube 136.

As will be described below, angled catheter 130 and “straight” catheter230 will be used in different method steps for treating various preparedopenings, naturally occurring ostia and ducts, and sinus cavities. It isalso to be noted that dimensions of the catheters are selected toaccommodate different conditions in the paranasal sinus system. Forexample, the outer diameters of the distal segments with the balloondeflated are selected so that the respective distal segments with theballoon deflated will fit snugly with the prepared openings, naturalostia or ducts and sinus cavities into which these distal segments areto be pushed. As already mentioned, the working inflated diameters ofthe balloons differ depending on the size required to treat differentparts of the paranasal sinus system. Accordingly, the surgeon must, atthe time surgery is begun, have available a set of sinus ballooncatheters which are angled or straight, the balloons of which haveappropriate inflated working diameters, and which have appropriate outerdiameters with the balloon deflated that will enable the catheter inquestion to be pushed into the respective prepared opening, naturalostium or duct or sinus cavity to be excised.

Turning to FIGS. 4 and 5, in a method of performing balloon catheterantrostomy of the maxillary ostium, the middle turbinate 20 is retractedmedially to gain access to the middle meatus 22. In some cases themiddle turbinate is resected. The ethmoid infundibulum 24 is exposed byusing cutting forceps 67 to remove part of the uncinate process 26 (FIG.4). Distal segment 137 of balloon catheter 130 is then pushed throughthe maxillary ostium 41 (which is in ethmoid infundibulum 24) into themaxillary sinus 21. As seen in FIG. 5, balloon 134 is inflated to 9 bars(atmospheres) for 20 seconds then deflated. Distal segment 137 ofballoon catheter 130 is slightly repositioned to insure full dilationand inflated again to 9 bars for 20 seconds. Balloon 134 is thendeflated, and catheter 130 is removed from the now enlarged ostium 41.

Turning to FIGS. 6 and 7, in a method of performing a middle meatalmaxillary antrostomy, an initial opening is made in the fontanelle 40(section of thin membranous tissue without bone of the medial maxillarysinus wall 42 which is also a portion of the lateral nasal wall 44).This is performed by bringing a 45 degree upbiting Blakesely punch 60into nasal cavity 38 along the lateral nasal wall 44 just superior tothe inferior turbinate 46 at the midpoint of its horizontal axis toperforate fontanelle 40 to create a new 3 mm opening 50 (FIG. 6). Thepunch 60 is removed, and sinus balloon catheter 130 is brought intonasal cavity 38 and pushed into the new opening 50 in fontanelle 40 oflateral nasal wall 44 (FIG. 7). Balloon 134 is inflated to 9 bars for 20seconds then deflated. Balloon catheter 130 is slightly repositioned inthe enlarged opening 50 to insure thorough dilation and inflated againto 9 bars for 20 seconds. Balloon catheter 130 is then deflated andwithdrawn from opening 50 and nasal cavity 38.

As seen in FIGS. 8 and 9, in a method of inferior meatal antrostomy, theinferior turbinate 46 has been displaced medially. A sharp dissector 64is introduced into nasal cavity 38 and used to perforate lateral nasalwall 44 in the inferior meatus 52 to create an opening 56 in lateralnasal wall 44 (FIG. 8). Dissector 64 is withdrawn from nasal cavity 38.The deflated balloon catheter 130 is introduced into the nasal cavity38, and distal segment 137 of balloon catheter 130 is pushed throughopening 56 in lateral nasal wall 44. The balloon 134 is inflated to 9bars for 20 seconds then deflated. Deflated balloon 134 is slightlyrepositioned to assure total dilation of the opening 56. A seconddilation of the balloon 134 to a pressure of 9 bars for 20 seconds isperformed. The balloon catheter 130 is then deflated and withdrawn fromopening 56 and nasal cavity 38.

A balloon catheter ethmoidectomy of the anterior ethmoid sinus is shownin FIGS. 10-12. The middle turbinate 20 (FIG. 5) has been refractedmedially to gain access to the middle meatus 22 (FIG. 5). In some cases,the middle turbinate may be partially or totally removed. The ethmoidinfundibulum 24 is exposed by removing part of the uncinate process 26(FIG. 4). A fine cutting forceps 66 is used to remove the anterior wall30 of the ethmoid bulla 28 (FIG. 10). After anterior wall 30 of ethmoidbulla 28 is removed, the straight balloon catheter 230 is brought intonasal cavity 38, and distal segment 237 is pushed into bulla 28 (FIG.11). Balloon 234 is inflated to 9 bars for 20 seconds then deflated.Balloon catheter 230 is then withdrawn from bulla 28. Distal segment 237of balloon catheter 230 is then pushed into the anterior ethmoid aircells 29 which lie posterior to the previously removed ethmoid bulla 28(FIG. 12). Balloon 234 is inflated to 9 bars for 20 seconds thendeflated. Balloon catheter 230 is then slightly repositioned to insurethorough dilation and inflated again to 9 bars for 20 seconds, deflated,and removed from the area of anterior ethmoid cells 29.

FIGS. 13 and 14 illustrate an ethmoidectomy of the posterior ethmoidsinus. When the posterior ethmoid sinus cells 31 must be removed, thebasal lamella 32 of the middle turbinate 20 is perforated with a punch68 (FIG. 13). Distal segment 237 of balloon catheter 230 is then pushedthrough the new opening 34 in the basal lamella 32 of the middleturbinate 20 into the posterior ethmoid air cells 31 and inflated 9 barsfor 20 seconds (FIG. 14). Balloon catheter 230 is then deflated,slightly repositioned, and again inflated 9 bars for 20 seconds. Ballooncatheter 230 is then deflated and withdrawn.

FIG. 15 shows sinusotomy of the sphenoid sinus. After anterior andposterior ethmoidectomy, distal segment 237 of balloon catheter 230 isinserted through the anterior wall 37 of sphenoid sinus 39 (FIG. 15).The balloon 234 is then inflated to 9 bars for 20 seconds then deflated.The balloon catheter 230 is slightly repositioned to insure thoroughdilation and inflated again to 9 bars for 20 seconds, then deflated, andwithdrawn.

FIG. 16 illustrates sinusotomy of the frontal sinus. After an anteriorethmoidectomy the nasofrontal duct 36 is exposed and in the surgeon'sview. The distal segment 137 of an angled catheter 130 with a 5 mminflated working diameter is brought into the frontnasal duct 36 andinflated to 9 bars, then deflated. The distal segment 137 of the ballooncatheter 130 is slightly repositioned to insure complete dilation of thenasofrontal duct 36 and inflated to 9 bars for 20 seconds then deflatedand withdrawn.

All of the above procedures may be performed in a similar fashion inpatients who have had previous sinus surgery and the sinus openings havebeen obstructed by scar tissue or granulation tissue.

1.-25. (canceled)
 26. A method of using a dilator to treat a patient,wherein the dilator comprises: (i) a first tubular elongate member bodyhaving a proximal segment and a distal segment, (ii) a balloon mountedlocated at the distal segment of the first tubular elongate member body,and (iii) a port located at the proximal segment of the first tubularelongate member body, wherein the port is configured to provide fluidunder pressure to inflate the balloon; wherein the method comprises: (a)pushing the distal segment of the first tubular elongate member body viathe proximal segment of the first tubular elongate member body toposition the distal segment of the first tubular elongate member bodyinto a space associated with a nasal sinus of the patient, wherein theballoon is in a deflated state during the act of pushing, the firsttubular elongate member body having sufficient stiffness and columnstrength to be pushed into the space; and (b) introducing fluid underpressure through the proximal segment of the first tubular elongatemember body to inflate the balloon and dilate the space.
 27. The methodof claim 26, wherein the first tubular elongate member body has a bendplacing the distal segment at an angle of 70° to 115° to the proximalsegment.
 28. The method of claim 27, wherein the angle is 90°.
 29. Themethod of claim 26, wherein the space is a maxillary ostium of thepatient's maxillary sinus, wherein the act of introducing fluid underpressure through the proximal segment of the first tubular elongatemember body to inflate the balloon and dilate the space comprisesdilating the maxillary ostium being to complete antrostomy of themaxillary ostium.
 30. The method of claim 29, further comprising: (a)retracting the patient's middle turbinate medially to gain access to thepatient's middle meatus; and (b) exposing the patient's ethmoidinfundibulum by removing part of the patient's uncinate process; whereinthe acts of retracting the patient's middle turbinate and exposing thepatient's ethmoid infundibulum are performed before the act of pushingthe distal segment of the tubular elongate member.
 31. The method ofclaim 26, further comprising preparing the space by forming an openingthrough the patient's fontanelle, wherein the act of forming comprises:(i) bringing a 45° upbiting Blakesely punch into the patient's nasalcavity along the patient's lateral nasal wall just superior to thepatient's inferior turbinate, and (ii) pushing the punch through thefontanelle to create the opening through the fontanelle; wherein the actof pushing the distal segment of the first tubular elongate member bodycomprises pushing the distal segment of the first tubular elongatemember body via the proximal segment of the first tubular elongatemember body to position the distal segment of the first tubular elongatemember body into the formed opening through the patient's fontanelle.32. The method of claim 26, wherein the space is a prepared openingformed through the patient's lateral nasal wall in the patient'sinferior meatus.
 33. The method of claim 32, further comprising: (a)displacing the patient's inferior turbinate medially; (b) introducing asharp dissector into the patient's nasal cavity; and (c) using thedissector to perforate the patient's lateral nasal wall in the inferiormeatus to form the prepared opening through the patient's lateral nasalwall in the patient's inferior meatus; wherein the acts of displacingthe patient's inferior turbinate, introducing a sharp dissector, andusing the dissector are performed before the act of pushing the distalsegment of the tubular elongate member.
 34. The method of claim 26,wherein the distal segment is positioned at an angle of 130° to 180° tothe proximal segment.
 35. The method of claim 26, wherein the distalsegment includes a slot, wherein the first tubular elongate member bodyis closed at a point distal to the slot.
 36. The method of claim 26,wherein the space is formed in the patient's ethmoid bulla.
 37. Themethod of claim 36, further comprising: (a) retracting the patient'smiddle turbinate is medially to gain access to the patient's middlemeatus; (b) exposing the patient's ethmoid infundibulum by removing partof the patient's uncinate process; and (c) using a fine cutting forcepsto remove an anterior wall of the ethmoid bulla; wherein the acts ofretracting the patient's middle turbinate, exposing the patient'sethmoid infundibulum, and using a fine cutting forceps are performedbefore the act of pushing the distal segment of the tubular elongatemember.
 38. The method of claim 37, further comprising removing theethmoid bulla.
 39. The method of claim 38, further comprising, afterremoving the ethmoid bulla: (a) pushing the distal segment of the firsttubular elongate member body into one of the patient's anterior ethmoidair cells lying posterior to the space formerly occupied by the ethmoidbulla, (b) inflating the balloon to dilate the anterior ethmoid aircells and thereby remove the anterior ethmoid air cells; (c) deflatingthe balloon; and (d) removing the distal segment from the space formerlyoccupied by the anterior ethmoid air cell.
 40. The method of claim 39,further comprising: (a) perforating the patient's basal lamella of thepatient's middle turbinate to form a second opening; (b) pushing thedistal segment of the first tubular elongate member body into aposterior ethmoid air cell; (c) inflating the balloon is inflated todilate and remove the posterior ethmoid cell; (d) deflating the balloon;and (e) removing the distal segment from the space formerly occupied bythe posterior ethmoid air cell.
 41. The method of claim 40, furthercomprising, after removing the distal segment from the space formerlyoccupied by the anterior ethmoid air cell and removing the distalsegment from the space formerly occupied by the posterior ethmoid aircell: (a) inserting the distal segment of the first tubular elongatemember body through the patient's anterior wall of the patient'ssphenoid sinus; (b) inflating the balloon for dilation and removal ofthe sphenoid sinus; (c) deflating the balloon; and (d) removing thedistal segment to complete sinusotomy of the sphenoid sinus.
 42. Themethod of claim 39, further comprising, after removing the distalsegment from the space formerly occupied by the anterior ethmoid aircell: (a) providing a second balloon elongate member, wherein the secondballoon elongate member comprises: (i) a second tubular elongate memberbody having a proximal segment and a distal segment, (ii) a balloonmounted located at the distal segment of the second tubular elongatemember body, and (iii) a port located at the proximal segment of thesecond tubular elongate member body, wherein the port is configured toprovide fluid under pressure to inflate the balloon; (b) pushing thedistal segment of the second tubular elongate member body via theproximal segment of the second tubular elongate member body into afrontonasal duct, wherein the balloon of the second balloon elongatemember is in a deflated state during the act of pushing the distalsegment of the second tubular elongate member body; (c) inflating theballoon of the second balloon elongate member to dilate the frontonasalduct; (d) deflating the balloon of the second balloon elongate member;and (e) removing the distal segment of the second tubular elongatemember body to complete a frontal sinusotomy.
 43. The method of claim26, wherein the dilator comprises a catheter.